Cancer: Herceptin

Lord Warner: My right honourable friend the Secretary of State for Health has made the following Written Ministerial Statement.
	On 24 May Roche, the manufacturers of Herceptin (trastuzumab), announced that the European Commission had granted a licence extension for Herceptin to include use in patients with HER2-positive early breast cancer.
	On 9 June the National Institute for Health and Clinical Excellence (NICE) published its draft guidance on Herceptin. It recommends the drug for women with early-stage HER2-positive breast cancer, except where there are concerns about cardiac function. The full draft recommendations are as follows:
	1.1 Trastuzumab, given at three-week intervals for one year or until disease recurrence, whichever is the shorter period, is recommended as a treatment option for women with early-stage HER2-positive breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy, if applicable.
	1.2 Cardiac function should be assessed prior to the commencement of therapy, and trastuzumab treatment should not be offered to women who have a left ventricular ejection fraction (LVEF) of 55 per cent or less, or who have any of the following: a history of documented congestive heart failure, high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiograph (ECG), and/or poorly controlled hypertension.
	1.3 Cardiac functional assessments should be repeated every three months during trastuzumab treatment. If the LVEF drops by 10 per cent from baseline and to below 50 per cent then trastuzumab treatment should be suspended. A decision to resume trastuzumab therapy should be based on a further cardiac assessment and a fully informed discussion of the risks and benefits between the individual patient and their clinician.
	These recommendations are subject to an appeal period, which closes on 28 June 2006. During this period registered stakeholder organisations, including those representing healthcare professionals, patients and carers, can appeal against the draft guidance. Final guidance is expected to be issued at the beginning of July 2006, assuming that there are no appeals.
	Once finalised, the recommendations will mean that all eligible patients with early-stage HER2-positive breast cancer should receive Herceptin on the NHS. Although the recommendations are subject to appeal, there are no national restrictions on the NHS using Herceptin in the interim, and the draft recommendations should, of course, be taken into account by primary care trusts.
	I would like to congratulate NICE on issuing its draft recommendations on Herceptin just two weeks after the drug was licensed for use in early breast cancer. This shows how the new single-technology appraisal process allows NICE to issue guidance within weeks of a licence being granted.
	The important thing now is for NHS cancer networks to ensure that all women diagnosed with early breast cancer receive a HER2 test to determine if they are HER2 positive and might therefore benefit from treatment with Herceptin.
	Professor Mike Richards, the national cancer director, is already working with cancer networks to ensure that testing arrangements are put in place. I am expecting an update from Professor Richards next week and I will ensure that both Houses receive a report on progress soon afterwards.

Control Orders

Baroness Scotland of Asthal: My right honourable friend the Secretary of State for the Home Department (John Reid) has made the following Written Ministerial Statement.
	Section 14(1) of the Prevention of Terrorism Act 2005 (the 2005 Act) requires me to report to Parliament as soon as reasonably practicable after the end of every relevant three-month period on the exercise of the control order powers during that period.
	During the period 11 March to 10 June 2006, three orders were made with the permission of the court under Section 3(1)(a) of the 2005 Act—two in respect of British citizens, on 5 April and 24 May 2006, and one in respect of a foreign national, on 16 May 2006. There are 14 control orders currently in force, five of which are in respect of British citizens.
	One request to modify a control order obligation was refused during the period. A right of appeal exists in Section 10(3) of the 2005 Act against a decision by the Secretary of State not to modify an obligation contained in a control order. This has not been exercised in respect of this refusal.

Coroner Reform Bill

Baroness Ashton of Upholland: My right honourable friend the Minister of State has made the following Written Ministerial Statement.
	On 6 February, I announced my intention to publish a draft Bill to reform the coroner system in England and Wales (Official Report, House of Commons, col. 608). The draft Bill will be laid and published today, and will also be available on the departmental website (www.dca.gov.uk/legist.htm). The draft Bill will be subject to pre-legislative scrutiny by the Constitutional Affairs Select Committee, and I am arranging for a separate strand of pre-legislative scrutiny by families who have recent experience of the coroners' service, which will assist honourable Members in their scrutiny of the Bill.

Education: Northern Ireland

Lord Rooker: My honourable friend the Parliamentary Under-Secretary of State for Northern Ireland (Maria Eagle) has made the following ministerial Statement.
	In December 2005 the draft Education (Northern Ireland) Order was published for consultation. Following consideration of the responses to the consultation and the views expressed to me in a series of meetings with key interests in Northern Ireland, I have laid the draft order before the House today.
	Copies of the draft order and Explanatory Memorandum, together with copies of a summary of the responses to the consultation on the draft Education (Northern Ireland) Order, which sets out the Government's response to the consultation, have been made available to the Vote Office and the Printed Paper Office.

EU: Employment, Social Policy, Health and Consumer Affairs

Lord Warner: My right honourable friend the Minister of State (Rosie Winterton) has made the following Written Ministerial Statement.
	The Employment, Social Policy, Health and Consumer Affairs Council met on 1 and 2 June. The health issues were taken on 2 June. Items on the main agenda were: the proposal for a directive of the European Parliament and of the Council amending directive 95/2/EC on food additives other than colours and sweeteners and directive 94/35/EC on sweeteners for use in foodstuffs; women's health; promotion of healthy lifestyles and prevention of type 2 diabetes; common values and principles in EU health systems; review of the EU Strategy for Sustainable Development; pandemic influenza preparedness and planning; combating HIV/AIDS; the proposal for a regulation of the European Parliament and of the Council on advanced therapy medicinal products and amending directive 2001/83/EC and regulation (EC) No. 726/2004; and the proposal for a directive of the European Parliament and of the Council amending council directives 90/385/EEC and 93/42/EEC and directive 98/8/EC of the European Parliament and the Council as regards the review of the medical devices directives.
	The council adopted the amendments to the additives and sweeteners directives by qualified-majority voting. The UK voted in favour of these.
	Council conclusions were adopted on women's health, and promotion of healthy lifestyles and prevention of type 2 diabetes.
	Council conclusions were also adopted on common values and principles in EU health systems. The UK expressed particular support for these, which build on conclusions agreed under the Irish presidency in 2004, reminding the European institutions of the importance of safeguarding the values and principles that underpin EU health systems in their work.
	There was a policy debate on the review of the EU Sustainable Development Strategy. Key themes included: recognition that improved health contributes to economic growth, addressing health inequalities, and the importance of the global dimension in promoting health in less developed countries. The UK spoke about the significant role employers could play in providing healthy workplaces and the value of sharing strategies for improving mental health.
	There was an exchange of views on the Commission communication on combating HIV/AIDS in the EU and in neighbouring countries. The communication received broad support and there was wide recognition of the need to focus on prevention activities, especially among at-risk groups. The UK emphasised the need for the EU to take HIV/AIDS into account in its near-neighbourhood policies and funding.
	There was a lunchtime discussion on pandemic influenza preparedness.
	The council received information from the presidency on progress in the ongoing discussions of the council pharmaceutical working group on the directives on advanced therapy medical products and medical devices.
	Under "any other business", the council heard a report from the presidency on the European Parliament's vote on 16 May that allowed a second reading agreement on the proposed regulation on nutrition and health claims on food, and on the proposed regulation on the addition of vitamins and minerals and other substances to food. Both regulations will come back to the council for adoption once the administrative processes to ensure legal and linguistic consistency have been completed.

Fishing: Northern Ireland

Lord Rooker: My honourable friend the Minister of State for Northern Ireland (Paul Goggins) has made the following ministerial Statement.
	Copies of the inland fisheries annual report of the Department of Culture, Arts and Leisure for 2004 have been placed in the Libraries of both Houses.
	The document provides details of the department's activities to conserve, protect and develop salmon and inland fisheries under the Fisheries Act (Northern Ireland) 1966 as amended and includes statistical information and income and expenditure details for the 2004-05 financial year.

Food Safety Promotion Board: Northern Ireland

Lord Rooker: My honourable friend the Parliamentary Under-Secretary of State for Northern Ireland (Paul Goggins) has made the following ministerial Statement.
	Copies of the Food Safety Promotion Board Annual Report 2004, incorporating financial statements for 2004, have been placed in the Libraries of both Houses. This document provides details of the Food Safety Promotion Board's activities, its performance and expenditure to the end of 2004.

NHS: Anti-social Behaviour

Lord Warner: My right honourable friend the Minister of State (Caroline Flint) has made the following Written Ministerial Statement.
	On 10 June 2006, the Department of Health launched a consultation on proposed measures to deal with anti-social individuals creating a nuisance or disturbance on National Health Service healthcare premises. In some areas of the NHS, certain individuals can divert resources away from healthcare provision by causing a nuisance or disturbance to patients and staff. This consultation document proposes introducing new legislation to give NHS health bodies new powers to tackle this problem. This paper seeks comments on the need for such legislation and all aspects of its formulation and use. The consultation period will close on 1 September 2006. Copies of the consultation document have been placed in the Library.

Prison Service: Business Plan 2006–07

Baroness Scotland of Asthal: My honourable friend the Parliamentary Under-Secretary of State for the Home Department (Mr Gerry Sutcliffe) has made the following Written Ministerial Statement.
	The Prison Service business plan for 2006–07, including the previously agreed key performance indicator targets, has been published today. Copies have been placed in the Library.

UN Central Emergency Relief Fund

Baroness Amos: My right honourable friend the Secretary of State for International Development (Hilary Benn) has made the following Written Ministerial Statement.
	I informed honourable Members on 9 March of the official launch of the United Nations (UN) Central Emergency Response Fund (CERF). The CERF is intended to provide UN humanitarian agencies with early funding so that they can respond immediately when a crisis strikes, and to enable them to channel funds to neglected emergencies.
	To date, the CERF total stands at $262 million from 42 donors, of which the UK is the largest single contributor, with $70 million (£40 million) for this first year of operation. The CERF has made an encouraging start, with $92 million committed to a number of humanitarian crises, the largest allocations of which are to the Horn of Africa ($25 million); Darfur ($20 million); the Democratic Republic of Congo ($17 million); Chad ($10 million); Niger ($6 million); Côte d'Ivoire ($2 million); and Burundi ($2 million).
	The UK has a seat on the CERF advisory group, which provides the UN's emergency relief co-ordinator with advice on the speed and appropriateness of fund allocations and examines performance and accountability. The group had its first meeting on 23 May.
	In the light of the CERF's encouraging start, and as part of our ongoing efforts to improve the quality and quantity of the UK's response to humanitarian crises, I am pleased to inform the House that I have approved a further commitment to the CERF of £120 million over the next three years, January 2007 to December 2009, which is conditional on DfID continuing to be satisfied with the results that the UN is achieving with the CERF. We will monitor closely the performance of the CERF to ensure that this investment is used to the best effect. I hope that this long-term commitment will encourage other donors to do likewise, thereby strengthening the financial sustainability of the CERF, and we will actively lobby key donors to this end.